710437Micro NeedleClosedGRD Proof of ConceptInnovate UKNemaura Pharma has developed a number of drug delivery systems focusing on delivery of drugs through the skin. We wish to undertake a proof of concept to deliver the Tdap vaccine (Tetanus, Diphtheria and Pertussis) using a solid micro-dose injector. The Tdap booster vaccine must be adminsitered several times over a persons life span, and also to pregnant women during the third trimester. Pertussis alone is a highly contagious bacterial disease caused by Bordetella pertussis and affects 48.5 million people worldwide yearly, resulting in nearly 295,000 deaths. In April and May 2012, pertussis was declared to be at epidemic levels in the US state of Washington. In September 2012, a similar epidemic of pertussis was seen in parts of the United Kingdom, with several babies dying as a result. The Tdap vaccine is currently administered by needle injection to children and adults and requires refrigeration; it is completely ineffective if stored at room temperature for more than 8 hours. The vaccine also causes serious adverse skin reactions in more than 1 in 10 people. Nemaura’s device is disposable, designed to deliver a solid dose that can therefore deliver the vaccine at a fraction of the volume required for a liquid injection, thus significantly minimising skin trauma and adverse events, and the solid nature of the dosage form allows enahnced stability at room and elevated temperatures without the need for refrigeration. This method of delivery has also been independently reported to have a dose sparing effect, leading to comparable efficacy at a reduced dose. These factors have the potential to collectively transform the delivery of the Tdap vaccine and numerous other vaccines.